Sofosbuvir

Sofosbuvir is a prescription medication used to treat the symptoms of Chronic Hepatitis C Virus (HCV) Infection. 

• Sofosbuvir is available under the following different brand names: Sovaldi

Adult and pediatric dosage

Tablet

• 400mg (Sovaldi, generic)

Oral pellets

• 150mg per packet
• 200mg per packet

Chronic Hepatitis C Virus (HCV) Infection

Adult dosage

• Genotype 1 or 4: 400 mg orally once a day plus ribavirin and peginterferon alfa for 12 weeks; may consider sofosbuvir plus ribavirin for 24 weeks in genotype 1 patients ineligible to receive a peg-interferon-based regimen
• Genotype 2: 400 mg orally once a day plus ribavirin for 12 weeks
• Genotype 3: 400 mg orally once a day plus ribavirin for 24 weeks
• Patients with hepatocellular carcinoma awaiting liver transplantation
  • For prevention of post-transplant HCV reinfection
  • 400 mg orally once a day plus ribavirin for up to 48 weeks or until the time of liver transplantation, whichever occurs first
• Ribavirin dosage regimen with sofosbuvir (genotypes 1, 2, 3, and 4)
  • Take with food
  • Below 75 kg: 500 mg orally two times a day
  • Above 75 kg: 600 mg orally two times a day
• Renal impairment (CrCl below 50 mL/min): Reduce dose (see prescribing information)
• Peginterferon alfa regimen with sofosbuvir (genotype 1 or 4)
  • Peginterferon alfa 2a: 180 mcg subcutaneously weekly
  • Peginterferon alfa 2b: 1.5 mcg/kg/week subcutaneous; not to exceed 150 mcg/week
  • Renal impairment (CrCl ≤50 mL/min): Reduce dose (see prescribing information)

Pediatric dosage

• Children below 3 years: Safety and efficacy not established
•  Children above 3 years
  • Below 17 kg: 150 mg (oral pellets) orally once a day
  • 17 to below 35kg: 200 mg (tablet or oral pellets) orally once a day
  • 35 kg: 400 mg (tablet or oral pellets) orally once a day
• Treatment duration
  • Ribavirin dosing
    • Below 47 kg: 15 mg/kg/day orally (divided dose in the morning and evening)  
    • 47-49 kg: 600 mg/day orally (i.e., 200 mg morning, 400 mg evening)
    • 50-65 kg: 800 mg/day orally (i.e., 400 mg morning, 400 mg evening)
    • 66-80 kg: 1000 mg/day orally (i.e., 400 mg morning, 600 mg evening)
    • Above 80 kg: 1200 mg/day orally (i.e., 600 mg morning, 600 mg evening)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Sofosbuvir include:

• fatigue,
• headache,
• nausea,
• insomnia,
• itching,
• anemia,
• weakness,
• rash,
• decreased appetite,
• chills,
• flu-like illness,
• fever,
• diarrhea,
• joint pain,
• irritability,
• low white blood cell count (neutropenia), and
• low blood cell count (pancytopenia).

Serious side effects of Sofosbuvir include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• right-sided upper stomach pain,
• vomiting,
• loss of appetite,
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes (jaundice),
• very slow heartbeats,
• chest pain,
• shortness of breath,
• confusion,
• memory problems,
• weakness,
• extreme tiredness, and
• lightheadedness

Rare side effects of Sofosbuvir include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Sofosbuvir has severe interactions with no other drugs.
• Sofosbuvir has serious interactions with the following drugs:
  • amiodarone
  • carbamazepine
  • eliglustat
  • erdafitinib
  • fosphenytoin
  • lasmiditan
  • oxcarbazepine
  • phenobarbital
  • phenytoin
  • rifabutin
  • rifampin
  • rifapentine
  • sotorasib
  • St John's Wort
  • erlotinibib
  • tipranavir
• Sofosbuvir has moderate interactions with the following drugs:
  • acalabrutinib
  • apalutamide
  • berotralstat
  • darolutamide
  • elagolix
  • elvitegravir/cobicistat/emtricitabine/tenofovir DF
  • encorafenib
  • fostemsavir
  • lonafarnib
  • oteseconazole
  • regorafenib
  • safinamide
  • sarecycline
  • stiripentol
  • tafamidis
  • tafamidis meglumine
  • tenofovir DF
  • tucatinib
• Sofosbuvir has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Contraindications applicable to combination therapy
• Combination with ribavirin
  • Hypersensitivity
  • Pregnancy or planning pregnancy, including men whose female partners are pregnant/planning to get pregnant
  • CrCl less than 50 mL/min
  • Pancreatitis
  • Hemoglobinopathies (e.g., thalassemia major, sickle cell anemia)
  • Coadministration with diagnosing
  • Autoimmune hepatitis, decompensated liver disease (Child-Pugh class B, C)
  • Use in neonates, and infants (contains benzyl alcohol)
• Combination with peg-interferon alfa
  • Autoimmune hepatitis, decompensated liver disease (Child-Pugh class B, C)
  • Use in neonates, and infants (contains benzyl alcohol)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Sofosbuvir?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Sofosbuvir?”

Cautions

• Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV DDAs, and who were not receiving HBV antiviral therapy; HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level (see Black Box Warnings and Dosing Considerations)
• Drugs that are potent P-GP inducers in the intestine (e.g., rifampin, St. John’s wort) may significantly decrease sofosbuvir plasma concentrations
• Serious symptomatic bradycardia may occur in coadministration with amiodarone in combination with another direct-acting antiviral (DAA), particularly in patients also receiving beta-blockers, or those with underlying cardiac comorbidities and/or advanced liver disease; coadministration is not recommended, if no alternative exists, inpatient cardiac monitoring is recommended for the first 48 hr and then daily home monitoring for at least the first 2 weeks
• Must NOT be used as monotherapy
• Use with other drugs containing sofosbuvir is not recommended
• Combination with ribavirin
  • Ribavirin may cause birth defects and fetal death; avoid pregnancy in female patients and female partners of male patients; patients must have a negative pregnancy test before therapy; use 2 or more forms of contraception, 1 of these forms of contraception can be a combined oral contraceptive product containing at least 1 mg of norethindrone (lower doses of norethindrone and other forms of hormonal contraception have not been studied or are contraindicated)
  • Risk of hemolytic anemia
  • Anemia associated with treatment may result in worsening cardiac disease
  • Potential carcinogen effects
  • Ocular disorders are reported when ribavirin is used in combination therapy with alpha interferons (e.g, decrease or loss of vision, retinopathy including macular edema, retinal artery or vein, thrombosis, retinal hemorrhages; cotton wool spots, optic neuritis, papilledema, serous retinal detachment)
  • A study in boys showed growth rate inhibited (i.e., height percentile decreases) with peginterferon alfa-2b plus ribavirin
  • Pancytopenia and bone marrow suppression was reported when coadministered with pegylated interferon and azathioprine
• Combination with peg-interferon alfa
  • Discontinue STAT if progressive ALT increases despite dose reduction or is accompanied by increased bilirubin or signs of hepatic decompensation
  • Caution in renal impairment
  • Risk of suicidal ideation and psychoses; discontinued if severe depression occurs
  • Safety and efficacy not established in patients with liver and other transplantations; as with other alpha interferons, liver and renal graft rejections have been reported
  • May cause myelosuppression; discontinue therapy (at least temporarily) if platelet count below 25,000/mm³ or ANC is below 500/mm³
  • Will likely experience flu-like symptoms in the early part of treatment
  • May cause development of exacerbation of several pathologic conditions
  • Reduce/discontinue if moderate/severe depression, see Manufacturer's package insert
  • In hepatic impairment, reduce/discontinue as suggested by the Manufacturer's package insert
• Drug interaction overview
  • Frequent monitoring of relevant laboratory parameters (e.g., International Normalized Ratio [INR] in patients taking warfarin, blood glucose levels in diabetic patients) or drug concentrations of concomitant medications such as cytochrome P450 substrates with a narrow therapeutic index (.g, certain immunosuppressants) is recommended to ensure safe and effective use; dose adjustments of concomitant medications may be necessary

Pregnancy & Lactation

• If therapy is administered with ribavirin or peginterferon alfa and ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant; refer to ribavirin and/or peginterferon alfa prescribing information for more information on ribavirin-and peginterferon alfa-associated risks of use during pregnancy
• No adequate human data is available to establish whether or not drug poses a risk to pregnancy outcomes
• Lactation
  • Not known whether sofosbuvir or metabolites are present in human breast milk, affect human milk production, or have effects on the breastfed infant; the predominant circulating metabolite of sofosbuvir (GS-331007) was the primary component observed in the milk of lactating rats, without effect on nursing pups
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from the drug or the underlying maternal condition
  • If the drug is administered with ribavirin, the nursing mother's information for ribavirin also applies to this combination regimen; refer to the ribavirin prescribing information for more information on use during lactation